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🍃Regulatory Roadmap

Regulatory Strategy

Phased approach to FDA approval, from device pathway to full biologics licensure.

Start
Month 0
510(k) Clearance
Month 24
BLA Approval
Month 60
Full Integration
Month 66+
PHASE 1

Cell-Free Construct

Pathway
510(k) / De Novo
FDA Center
CDRH
Timeline
18-24 months

Hydrogel + 4 growth factors only. Device classification as combination product (device-led).

Key Milestones

Pre-submission meeting
Month 3
Biocompatibility testing
Month 6
Preclinical efficacy
Month 12
510(k)/De Novo submission
Month 18
FDA clearance
Month 24

Key Considerations

  • •Predicate devices: EMD (Emdogain), GEM 21S
  • •Special controls for growth factor combination
  • •Biocompatibility per ISO 10993
  • •Shelf-life stability studies
PHASE 2

Construct + Cells

Pathway
BLA (Biologics License Application)
FDA Center
CBER
Timeline
36-48 months

Addition of autologous or allogeneic cells. Regulated as biologic product.

Key Milestones

Pre-IND meeting
Month 24
IND submission
Month 30
Phase I trial
Month 36
Phase II trial
Month 48
BLA submission
Month 60

Key Considerations

  • •RMAT designation eligibility
  • •Cell sourcing and characterization
  • •Manufacturing under cGMP for biologics
  • •Clinical endpoints for regeneration
PHASE 3

Vertical Integration

Pathway
BLA Supplement
FDA Center
CBER
Timeline
48-60 months

In-house cell sourcing and manufacturing. Supply chain control and margin optimization.

Key Milestones

Manufacturing facility qualification
Month 48
Process validation
Month 54
BLA supplement submission
Month 60
Approval and launch
Month 66

Key Considerations

  • •CMC supplement for manufacturing changes
  • •Comparability studies
  • •Domestic sourcing qualification
  • •Scale-up validation

Why 510(k) First?

  • ✓Fastest path to market (18-24 months vs 5+ years for BLA)
  • ✓Generates revenue to fund Phase 2 development
  • ✓Builds clinical evidence in real-world use
  • ✓Establishes manufacturing and QA systems
  • ✓Creates commercial infrastructure

RMAT Designation Strategy

Regenerative Medicine Advanced Therapy (RMAT) designation may be pursued for Phase 2 product to enable:

  • •Early FDA interactions
  • •Rolling BLA submission
  • •Priority review
  • •Accelerated approval pathway

FDA Engagement Strategy

📞

Pre-Sub Meeting

Validate device classification and testing strategy

📋

Q-Sub

Address specific technical questions pre-submission

📝

510(k) Review

90-day review period with interactive review

✅

Clearance

Market authorization and commercial launch